Vol. 14, No. 2, February 2018 Happy Trials to You What Does a Consent Form Look Like at Different Reading Levels? By Norman M. Goldfarb For informed consent to occur, potential study participants should be able to read and understand the informed consent form. However, many clinical research informed consent forms are written at a reading grade level that is above the capacity of study participants to understand. To lower the reading grade level, the text can be simplified by reducing the average length of words and sentences, as well as the difficulty of the words. However, does simplifying the text also remove case significant semantic meaning? To find out, the author took five passages from a consent form written at a high reading grade level. He then simplified the passages three times, each with a progressively lower reading grade level. Appendix 1 shows the results, with reading grade levels of 18.3, 10.9, 7.5 and 4.9, according to the Flesch-Kincaid scores in Microsoft Word. The reading levels of individual passages are also noted. (It should be noted, however, that readability experts question the validity of readability scoring tools on short passages.) This exercise yields the following conclusions: It is possible to increase readability in these consent form passages. Editing text just to reduce its reading grade level score can be counterproductive. It is relatively easy to decrease the reading grade level, to some extent, by breaking long sentences into short ones, but this technique can disturb the semantic flow and reduce actual readability. The most effective way to increase readability is to identify the key semantic points, express them in simple terms, and discard the rest. The result is a document that is both shorter and more readable. However, the simplified text does not preserve details that might be significant. The nuanced legal protections that might seem to be the primary objective of some consent forms are difficult to preserve when readability increases. However, the validity of informed consent relies on the ability of the reader to understand the consent form s content. Certain content naturally lends itself to certain reading levels. It would be very difficult to achieve both a consistent level of semantic sophistication and a consistent reading level across a document as long and varied as a consent form. Performing the exercise revealed wording errors in the original text and ways to clarify the text at the original reading level without any loss of meaning. Conclusion Before publishing an informed consent form, the authors should make a serious effort to simplify the content. They are likely to find that readability can be improved, to some extent, without any loss of meaning. They should also consider removing complicating details to increase readability and shorten the document. Improving readability in any part of a consent form improves readability for the entire form, so readers can save their cognitive energy for the most difficult passages.
Related Reading 1. Readable Informed Consent Forms Are Not Optional, Norman M. Goldfarb, The Journal of Clinical Research Best Practices, September 2005 2. How Well Does the Average U.S. Adult Read?, Norman M. Goldfarb, The Journal of Clinical Research Best Practices, September 2005 3. Informed Consent Form Makeover, Norman M. Goldfarb and William H. DuBay, The Journal of Clinical Research Best Practices, May 2006 4. Writing Good at a Seventh-Grade Reading Level, Norman M. Goldfarb and William H. DuBay, The Journal of Clinical Research Best Practices, January 2006 5. Measuring Informed Consent Readability in Microsoft Word, Norman M. Goldfarb, The Journal of Clinical Research Best Practices, July 2006 6. The Three-Page Informed Consent Form, Norman M. Goldfarb, The Journal of Clinical Research Best Practices, January 2012 Acknowledgments The author thanks Jennifer I. Kucera of the University of Nebraska for providing the original consent form. The author thanks William H. DuBay for assisting with the text simplifications. Author Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information, consulting and training services. Contact him at 1.650.465.0119 or ngoldfarb@firstclinical.com. 2
Appendix 1. Informed Consent Language at Four Reading Grade Levels 18.3 Reading Grade Level 10.9 Reading Grade Level 7.5 Reading Grade Level 4.9 Reading Grade Level In the event of your death, the study doctor or his/her representative will seek copies of your medical records regarding your death from your primary care or heart physician. This may include emergency room records, records from office or clinic visits, and hospital records. This information will be used for research purposes only and will be kept confidential. Because this is vital information, your family will be encouraged to allow recording of the information from the device or allow the removal of the device, the leads and surrounding tissue, if necessary, for evaluation by Acme Medical. (14.3) The ICD implant is a common surgical procedure and, although the known risks associated with this surgery are minimal, they may include but are not limited to: infection, bleeding, blood clot, injury to the vein wall, tear of the vein or heart tissue, air in the vein, heart or chest, inflammation of the lining of the heart, bruising at the ICD pouch, an allergic or physiologic reaction to the substance used by the doctor to visualize the heart (allergic reaction to contrast media or renal failure), stroke, heart attack, buildup of fluid and/or pressure around the heart, damage to the heart valves, In the event of your death, we will seek copies of your medical records regarding your death from your physicians. This information will be used for research purposes only and will be kept confidential. We will ask your family to let us record information from the device or allow us to remove it for evaluation by Acme Medical. (10.6) The ICD implant is a common surgical procedure. The known risks of this surgery are minimal. They include but are not limited to: irregular heartbeats, infection, bleeding, blood clot, injury to the vein wall, tear of the vein or heart tissue, air in the vein, heart or chest, and inflammation of the lining of the heart. There may be bruising at the ICD pouch or an allergic or physiologic reaction to the substance used by the doctor to visualize the heart. You might experience a stroke, heart attack, buildup of fluid and/or pressure around the heart, damage to the heart If you die, we will ask your doctors for your medical records. We will keep them confidential. We will ask your family to let us record information from the device or let us to remove it for evaluation by Acme Medical. (7.5) Implanting an ICD is a common surgical procedure. The known risks of surgery are minimal, but they include: infection, bleeding, or blood clot. Your heart, veins, lungs or chest may be injured. You may experience inflammation, swelling or an allergic reaction. You might have a stroke or heart attack. (6.3) If you die, we will ask your doctors and family to help us find out what happened. (5.6) Installing an ICD is done a lot. Problems are rare, but you might have one. You may get an infection. Something might happen to your heart, lungs, brain, veins or chest. You might also get an infection, swelling or an allergic reaction. (3.0) 3
collapse of a lung, movement of the wires (leads) from the original location, movement of the ICD from its original location, a change in the interaction between the ICD and the heart, and irregular heartbeats. (55.9) The medically necessary hospital and doctor fees associated with deciding whether you can be enrolled in this study, the implant procedure, and follow-up visits will be your responsibility along with any copayments and deductibles that you would normally be expected to pay. How much you will have to pay depends on whether or not you have health insurance and what services your insurance company will cover. If you have any questions concerning your insurance coverage, you should speak to your insurance company prior to agreeing to take part in this research study. (17.0) The sponsor agrees to pay for the reasonable and necessary treatment of injuries, undesirable side effects, or adverse reactions that are caused by study procedures that are not standard of care for you or that are caused by a defect or malfunction of the study device during the study. The sponsor is not responsible for medical risks or conditions that you would face if you were not in the study. Accepting the sponsor s payment does not limit or waive any rights that you may have valves, or collapse of a lung, There may be movement of the wires (leads) from the original location, movement of the ICD from its original location, or a change in the interaction between the ICD and the heart. (12.4) You will be responsible for the hospital and doctor fees for deciding whether you can be enrolled in this study, the implant procedure, and followup visits. You will also be responsible for any copayments and deductibles that you would normally have to pay. Before you agree to join the study, talk to your insurance company about your coverage. (12.0) The sponsor will pay for the reasonable and necessary treatment of any medical problems caused by the ICD or study procedures that are not standard of care for you. The sponsor is not responsible for medical risks or conditions that you would face if you were not in the study. Accepting payment from the sponsor does not limit or waive any rights you may have against the sponsor. The sponsor does not admit liability by any offer Your doctor and the hospital will charge fees to help you decide whether to join the study. There will also be fees for the implant procedure and follow-up visits. Before you agree to join the study, talk to your insurance company about your coverage. (8.0) The sponsor will pay for certain injuries or side effects caused by the ICD or surgery. It is not responsible for any problems you would face if you were not in the study. If it pays you any money, it does not limit your rights. If it offers a payment, the payment does not mean the sponsor admits the problem is its fault. (6.2) Talk to your doctor and insurance company about what the study will cost you. (7.5) If the study injures you, the sponsor might pay for treatment. If you are injured in the study, talk to someone about your legal rights. (5.8) 4
against the sponsor, and the sponsor does not admit liability by offering payment in any amount. (15.9) of payment. (10.1) Participation in this research study may result in a loss of privacy, since persons other than the investigator might view your study records. Unless required by law, only the study investigator, members of the investigator s staff, representatives of Acme Medical, as the sponsor of the research study, the hospital s Institutional Review Board, and representatives from the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration (FDA) and other U.S. and international regulatory or administrative bodies will have authority to review and copy your study records. If you should have any complications during this study, your entire medical history may need to be reviewed. They are required to maintain confidentiality regarding your identity. The information collected during this study may be added to research databases and used in the future by the hospital to study better measures of safety and effectiveness, develop a better understanding of disease(s) included in the study, or improve the efficiency, design and study methods of future clinical studies. Results of this study may be used for teaching, publications, People other than the investigator will see your records and maybe also your name. Unless required by law, only the investigator, study personnel, the hospital s ethics committee, people from Acme Medical, and people from government agencies will be able to see or copy your records. If you have any side effects, doctors and nurses may need to see your entire medical history. All these people have to keep your information private. Data collected during this study may be added to databases for future medical research. It might also be used for teaching, publications, scientific presentations, and insurance purposes. In such cases, your name or other identifying data will be kept secret. (11.1) People other than the investigator might see your records. The staffs of the investigator, the hospital, the sponsor, the ethics committee, and various government agencies are allowed to see your records. All these people have to keep your information private. Data from this study may also go into research databases for future medical research. Your data may also be used for teaching, publications and payment. In such cases, your name or other identifying data will be kept secret. (9.7) The investigator and other people will see your records, but only if there is a good reason. They will have to keep them private. (5.8) 5
presentations at scientific meetings, reimbursement purposes, and to support future clinical research studies. If your individual results are discussed, your name or other identifying information will not be used. (18.2) 6